Controlled urinary incontinence treatment

ES 2 249 407 T3

DESCRIPTION

Controlled treatment of urinary incontinence.

The present invention relates to a urinary incontinence treatment apparatus, comprising an implantable restriction device in a patient suffering from urinary incontinence to couple the urethra or urinary bladder to form a restricted urinary passage in the urethra or urinary bladder, in wherein the restriction device is operable to change the restriction of the urinary passage. The apparatus further comprises a power source that is external to the patient's body when the restriction device is implanted therein.

Urinary incontinence is a widespread problem. Many people are helped by training the pelvic base muscles but too many have severe problems with urinary leakage. Many different solutions have been tried to this problem. For example, an anterior, manually operated urinary incontinence treatment apparatus having an artificial hydraulic sphincter device that engages the urethra and connects to an elastic reservoir implanted in the scrotum or labia majora region. A disadvantage of this prior apparatus is that hard fibrosis develops around the reservoir over time, which can cause the pump components to malfunction. Additionally it is a rather complicated task to manually squeeze the implanted, elastic reservoir to pump hydraulic fluid to open the sphincter device when the patient needs to urinate. In particular, the woman can be left with wet fingers. The fibrosis created sooner or later will become a hard fibrotic layer, which can make it even more difficult to pump the reservoir. A further disadvantage is that the use of hydraulic fluid always carries a risk of fluid leakage from implanted hydraulic components.

An earlier hydraulic apparatus designed to compress the urethra is described in US Patent No. 5,520,606. Prosthetic sphincters with an inflatable end, surrounding the urethra or enclosing it on two sides are described for example in US Patent Nos. 4,571,749 and 4,222,377. United States Patent No. 4,969,474 describes a hydraulic procedure to treat both men and women with urinary incontinence problems in the same way. The apparatus of US Patent No. 4,969,474 includes a reservoir containing fluid and an inflatable compression means designed to compress the urethra without risk of tissue loss or necrosis. An artificial, hydraulically operated urethral sphincter employing an external magnet to achieve closure of the end of the urethra is described in US Patent No. 5,562,598.

An anterior mechanical prosthetic sphincter, described in US Patent No. 4,619,245, comprises a manually controllable actuator component for implantation at a convenient site in the patient's body. US Patent No. 5,509,888 describes another implantable check valve device whereby a flow of fluid can be constrictively occluded in a passageway, such as the urethra.

The object of the present invention is to provide a new, convenient urinary incontinence treatment apparatus, the performance of which can be affected by the patient at any time after the operation, in particular, when various needs arise during the course of the day, so that the patient is always substantially satisfied or comfortable.

This object is achieved by a urinary incontinence treatment apparatus as described in claim 1, characterized in that a source of energy is provided, which is intended to be external to the patient's body when the restriction device is implanted in he. The external power source adapts to release wireless power. An implantable energy transformation device is also provided to transform released wireless energy into storable energy. Furthermore, the internal source of energy is capable of storing the storable energy, and the control device is adapted to control the internal source of energy in order to supply energy for the operation of the restriction device. Additionally, the control device, in turn, comprises a first control unit and a second control unit. The first control unit is operable from outside the patient's body to provide a control signal, and the second control unit implantable in the patient and adapted to control the control device in response to the control signal.

As a result, the advantage is achieved that the restriction device can be operated non-invasively, when the restriction device has to be adjusted. Additionally, the apparatus of the invention provides a simple and effective control of the power supplied to the implanted components of the apparatus that ensures extended and reliable functionality of the apparatus, possibly

As a result, the advantage is achieved that the restriction device can be operated non-invasively, when the restriction device has to be adjusted. Additionally, the apparatus of the invention provides simple and effective control of the energy delivered to the implanted components of the apparatus that ensures extended and reliable functionality of the apparatus, possibly for the remainder of the patient's life and at least many years.

The control device can also control the restriction device. The control device may comprise an internal control unit, preferably including a microprocessor, implantable in the patient to control the restriction device. The control device may further comprise an external control unit outside the patient's body, wherein the internal control unit is programmable by the

ES 2 249 407 T3 external control unit, for example, to control the restriction device during time. Alternatively, the internal control unit can control the restriction device for the time according to a schedule of activities, which can be tailored to the needs of the patient.

A great advantage is that the patient is trained to adjust the restriction of the urinary passage by using the control device wherever they like during the day.

Conveniently, the external control unit can load the internal control unit with data according to a loading mode only authorized by a doctor. For specialized controls of the restriction device, the external control unit can control the internal control unit according to a doctor mode only authorized by the doctor. For simple controls of the restriction device, the external control unit can control the internal control unit according to a patient mode allowed for the patient. In this way, by using the external control unit according to different modes, it is possible to have certain functions of the restriction device controlled by the patient and other more advanced functions controlled by the doctor, allowing flexible post-operative treatment of the patient. .

The control device may be adapted to control the energy source to release external energy to intermittently release energy in the form of an energy pulse train, for direct use in connection with the operation of the restriction device. According to a suitable embodiment, the control device controls the energy source to release electrical energy and the apparatus further comprises an implantable capacitor to produce the energy pulse train from the released energy. In this case, the term "direct" is used to mean, on the one hand, that the released energy is used while it is being released by the control device, on the other hand, that the released energy can be delayed somewhat, in the order of seconds, for example by an energy stabilizer before it is used in connection with the operation of the restriction device. The restraint device can be operated in a non-manual, non-magnetic or non-mechanical manner by using the released energy.

According to a preferred embodiment of the invention, the apparatus comprises implantable electrical components that include at least one, or only a single voltage level protector and a capacitor or accumulator, in which the charging and discharging of the capacitor or accumulator is controlled by the use of the voltage level protector. As a result, there is no need for any implanted current detector and / or current level detector for capacitor control, which makes the apparatus simple and reliable.

In general, the apparatus further comprises a patient implantable operating device for operating the restriction device, wherein the control device controls the operating device for operating the restriction device. The control device can directly supply the operating device with the energy released from the energy source and / or supply the other implantable energy consuming components of the apparatus. In this case, the term "directly" is used to mean, on the one hand, that the operating device is powered by the energy released while the latter is being released by the control device, on the other hand, that the Released energy can be delayed somewhat, on the order of seconds, for example by an energy stabilizer before the operating device is actuated. The advantage of using energy directly as it is released is that the apparatus can be very simple in design and the few components included make the apparatus reliable.

The control device can release magnetic, electromagnetic, kinetic, sonic or thermal energy, or non-magnetic, non-sonic, non-thermal, non-electromagnetic, or non-kinetic energy.

However, preferably, the operating device comprises an electrical operating device.

Typically, the apparatus of the invention comprises an adjustment device for adjusting the restriction device to change the restriction of the urinary passage. The adjustment device can be adapted to mechanically adjust the restriction device. Alternatively, the adjusting device can be adapted to hydraulically adjust the restriction device by using hydraulic means that are devoid of hydraulic fluid of the kind that has a viscosity that increases substantially when exposed to heat or a magnetic field, i.e. That is, the hydraulic fluid will not become more viscous when exposed to heat or it will be influenced by magnetic forces.

The restriction device may be non-inflatable, that is, without hydraulic fluid comprised for the adjustments of the restriction device. This eliminates problems with fluid leakage from the restriction device.

The operating device may comprise hydraulic means and at least one valve for controlling a flow of fluid from the hydraulic means. The control device may suitably comprise a wireless remote control for controlling the valve. The restriction device may comprise hydraulic means and the operating device may comprise a reservoir forming a fluid chamber with a variable volume connected to the hydraulic means. The operating device can distribute fluid from the chamber to the hydraulic means by reducing the volume of the chamber and withdraw fluid from the hydraulic means to the chamber by expanding the volume of the chamber.

The external source of energy can be of any conceivable kind, such as a nuclear source of energy or a chemical source of energy.

ES 2 249 407 T3

The internal source of energy preferably comprises an electric accumulator. The electric accumulator can comprise at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. A battery may be implanted in the patient to supply electrical power to the implanted electrical power consuming components of the apparatus in addition to supplying the wireless power. Where the control device comprises an implantable control unit, the electronic circuitry thereof and the restriction device can be powered directly by the transformed wireless energy or energy from either the implantable energy storage device or the battery.

Wireless power can be used directly for the operation of the restriction device, that is, the restriction device is operated as the wireless energy is released from the external power source by the control device. In this case, the term "directly" is used to mean, on the one hand, that the restriction device is operated in a timely manner by using the released energy without first storing the latter, on the other hand, that the released energy can be delaying something, on the order of seconds, for example, by an energy stabilizer before it is used for the operation of the restriction device. As a result, very simple control of the restriction device is achieved and only a few implanted components of the apparatus are achieved. For example, there is no complicated signal control system in place. This gives the advantage that the apparatus will be extremely reliable.

In general, the control device directly or indirectly controls and powers the operating device with wireless power released from the external power source and / or powers the other implanted power-consuming components of the apparatus.

In a first particular embodiment of the invention, the operating device comprises a motor, preferably an electric motor that can have electrically conductive parts made of plastic. The motor may include a rotary motor, wherein the control device is adapted to control the rotary motor to rotate a desired number of revolutions. Alternatively, the motor may include a linear motor, or a hydraulic or pneumatic fluid motor, in which the control device is adapted to control the flow of fluid through the fluid motor. The engines currently available on the market are getting smaller and smaller. Additionally, there is a wide variety of control procedures and miniaturized control equipment available. For example, several revolutions of a rotating motor can be analyzed by a Hall element with only a few mm in size.

In a second particular embodiment of the invention, the control device is adapted to change the polarity of the energy released to reverse the operating device. The operating device may suitably comprise an electric motor and the released energy may comprise electrical energy.

In a third particular embodiment of the invention, the restriction device is operable to perform a reversible function and there is an implantable inversion device in the patient to reverse the function performed by the restriction device. This reversal function preferably comprises the enlargement and restriction of the urinary passage through the restriction device, suitably in a progressive manner. In this regard, the control device suitably controls the reversal device, which may include a switch, to reverse the function performed by the restriction device. The reversing device may comprise hydraulic means including a pump for changing the flow direction of a fluid in the hydraulic means. Alternatively, the reversing device may comprise a mechanical reversing device, such as a commutator or gearbox.

Where the reversing device comprises a switch, the control device suitably controls the operation of the switch by changing the polarity of the released energy supplied to the switch. The switch may comprise an electrical switch and the power source may supply electrical power for the operation of the switch. The aforementioned switch may comprise an electronic switch or, where applicable, a mechanical switch.

According to the third particular embodiment, the operating device preferably comprises a motor, in which the reversing device reverses the motor.

In a fourth particular embodiment according to the invention, the restriction device comprises hydraulic means, for example, including an expandable / contractable cavity for fluid. Preferably, the operating device is adapted to conduct hydraulic fluid in the hydraulic means and comprises a motor, a valveless fluid conduit connected to the hydraulic means of the restriction device and a reservoir for fluid, in which the reservoir forms part of the duct. The operating device suitably comprises a pump operated by the motor. All the hydraulic components involved are preferably devoid of any non-return valve. This is of great advantage, because with the included valves there is always the risk of malfunction due to improperly working valves, especially when long periods of time elapse between valve operations. The reservoir can form a fluid chamber with a variable volume and the pump can distribute fluid from the chamber to the hydraulic means of the restriction device by reducing the volume of the chamber and withdrawing fluid from the hydraulic means to the chamber by expanding the volume. of the camera.

The internal implantable source of energy may comprise an accumulator, preferably an electrical source of energy, such as a battery having a life time of at least 10 years.

ES 2 249 407 T3

The apparatus may comprise a switch implanted in the patient to directly or indirectly switch the power supply from the internal power source. This solution is advantageous for embodiments of the apparatus that have a relatively high power consumption that cannot be met by direct wireless power supply.

According to a first alternative, the switch switches between an off mode, in which the internal power source is not in use, and an on mode, in which the internal power source supplies power for the operation of the restriction device. . In this case, the switch is conveniently operated by wireless energy released from the external power source to the switch between off and on modes. The control device, preferably comprising a wireless remote control, can control the external power source to release the wireless power. The advantage of this embodiment is that the life time of the implanted power source, such as a battery, can be significantly extended, since the implanted power source does not supply power when the switch is in its off mode.

According to a second alternative, the control device comprises a wireless remote control to control the internal source of energy. In this case, the switch is operable by wireless power from the external power source to switch between an off mode, in which the internal power source and the remote control are not in use, and a standby mode, in the which the remote control is allowed to control the internal power source to supply power for the operation of the restriction device.

In a third alternative, the apparatus further comprises an energy transformation device implanted in the patient to transform the wireless energy into storable energy to be stored in the internal energy source. The apparatus may further comprise an additional internal source of energy implantable in the patient to supply energy for operation of the restriction device, wherein the switch is power operable from the internal source of energy to the switch between an "off" mode, in which the internal source of additional power is not in use, and an "on" mode, wherein the internal power source supplies power for the operation of the restriction device. In this alternative, the control device controls the internal power source to operate the switch.

The internal energy source preferably comprises an electrical accumulator, at least one capacitor or at least one rechargeable battery or a combination of at least one capacitor and at least one rechargeable battery.

The internal source of energy preferably comprises an electrical source of energy, such as an accumulator or a battery that has a life time of at least 10 years. However, other kinds of sources are also conceivable, such as a nuclear power source or a chemical power source.

All of the above embodiments can be combined with at least one implantable sensor to sense at least one physical parameter of the patient, wherein the monitoring device can control the restriction device in response to signals from the sensor. For example, the sensor may comprise a pressure sensor to directly or indirectly sense pressure in the urethra or urinary bladder. The term "indirectly sensing pressure in the urethra or urinary bladder" is to be understood to encompass cases where the sensor senses pressure against the restraint device or human tissue of the patient. Where the control device comprises an internal control unit to be implanted in the patient, the internal control unit can suitably directly control the restriction device in response to sensor signals. In response to signals from the sensor, for example pressure, the position of the patient or any other important physical parameter, the internal control unit can send information therein to the outside of the patient's body. The control unit can also automatically control the restriction device in response to signals from the sensor. For example, the control unit may control the restriction device to firmly close the urinary passage in response to the sensor sensing that the patient is sitting, or to enlarge the urinary passage in response to the sensor sensing abnormally high pressure against the restraint device.

Where the control device comprises an external control unit outside the body of the patient, the external control unit can directly control the restriction device in a suitable manner in response to signals from the sensor. The external control unit can store information of the physical parameter perceived by the sensor and can be operated manually to control the restriction device based on the stored information. Furthermore, there may be at least one implantable emitter to send information of the physical parameter perceived by the sensor.

An external data communicator may be provided outside of the patient's body and an internal data communicator to be implanted in the patient may be provided for communication with the external data communicator. The internal data communicator may feed data relative to the patient, or relative to the restriction device, back to the external data communicator. Alternatively or in combination, the external data communicator can feed data to the internal data communicator. The internal data communicator can suitably feed data related to at least one physical signal from the patient.

The restriction device can be operated to open and close the urinary passage or it can progressively control the restriction of the urinary passage. A pressure sensor can be provided to directly or indirectly sense pressure in the urethra or urinary bladder. The control device can control the restriction device in response to signals from the pressure sensor.

ES 2 249 407 T3

The apparatus may comprise an implantable energy transformer device, wherein the control device releases electrical energy and the energy transformer device transforms electrical energy into kinetic energy for preferably direct operation of the restriction device. Suitably, an implantable stabilizer, such as a capacitor or rechargeable accumulator or the like, can be provided to stabilize the electrical energy released by the control device. Furthermore, the control device can control the energy source to release energy for a specified period of time or in a specified number of energy pulses. Finally, the restraint device can be non-inflatable.

All of the above embodiments are preferably remotely controlled. In this way, the control device advantageously comprises a wireless remote control that transmits at least one wireless control signal to control the restriction device. With this remote control it will be possible to adapt the function of the apparatus to the need of the patient on a daily basis, which is beneficial with regard to the treatment of the patient.

The wireless remote control may be capable of obtaining information on the condition of the restriction device and the control of the restriction device in response to the information. Also, the remote control may be capable of sending information regarding the restraint device from inside the patient's body to the outside of the patient.

In a particular embodiment of the invention, the wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient. In another particular embodiment of the invention, the wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable in the patient.

The remote control can transmit a carrier signal to carry the control signal, wherein the carrier signal is modulated in frequency, in amplitude or in frequency and amplitude and is a digital, analog or digital and analog signal. Also the control signal used with the carrier signal can be frequency, amplitude or frequency and amplitude modulated.

The control signal may comprise a wave signal, for example, a sound wave signal, such as an ultrasound wave signal, an electromagnetic wave signal, such as an infrared light signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an x-ray radiation signal, or a gamma radiation signal. Where applicable, two or more of the above signals can be combined.

The control signal can be digital or analog and can comprise an electric or magnetic field. Suitably, the wireless remote control can transmit an electromagnetic carrier wave signal to carry the control signal, digital or analog. For example, the use of an analog carrier wave signal carrying a digital control signal will give secure communication. The control signal can be transmitted in pulses by the wireless remote controller.

In all the above solutions, the control device advantageously releases energy from the energy source in a non-invasive, magnetic, non-magnetic, mechanical or non-mechanical manner.

The control device can release magnetic, electromagnetic, kinetic, or thermal energy, or non-magnetic, non-thermal, non-electromagnetic, or non-kinetic energy.

The control device can be activated in a non-manual or manual way to control the power source to release power.

The above-presented embodiments of the invention can be modified in accordance with the following suggestions. The released energy can comprise electrical energy and an implantable capacitor having a capacity of less than 0.1 pF can be provided to produce the energy pulse train, mentioned above.

An implantable motor or pump may be provided to operate the restriction device, wherein the control device is adapted to control the power source to directly power the motor or pump with the released energy. Specifically, the control device can be adapted to release wireless energy in the form of a magnetic field or electromagnetic waves (excluding radio waves) for direct power to the motor or pump, as the wireless energy is being released. When using a pump it is preferred that it is not a plunger type pump.

In general, wireless power comprises a signal.

The apparatus may further comprise an implantable energy transforming device for transforming wireless energy directly or indirectly into energy other than wireless energy, for the operation of the restriction device. For example, the motor or pump can be powered by the transformed energy.

The energy transformer device can transform wireless energy in the form of sound waves, preferably directly, into electrical energy for the operation of the restriction device. The

ES 2 249 407 T3 energy transformation device may comprise a capacitor adapted to produce electrical pulses into transformed electrical energy.

The motor mentioned in the present specification can also be driven directly with the wirelessly transmitted electromagnetic or magnetic energy in the form of signals, as the energy is transmitted. Additionally, all of the various engine functions and associated components described herein can be used where applicable.

In general, the restriction device is advantageously embedded in a soft or gel-like material, such as a silicon material having a hardness of less than 20 Shore.

Of course, the restriction device is preferably non-manually adjustable.

All of the various components described above, such as the motor, pump and capacitor, can be combined in the different embodiments where applicable. Also, the various functions described in relation to the previous embodiments of the invention can be used in different applications, where applicable.

All of the various ways of transferring energy and controlling energy present in the present specification can be practiced using all the various components and solutions described.

The present invention also provides methods for treating urinary incontinence patients. These procedures are not part of the invention but are useful for understanding the invention.

Accordingly, according to a first alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising the steps of implanting an operable restriction device in the patient so that the restriction device engages the urethra. or urinary bladder to form a restricted urinary passage in the urethra or urinary bladder, providing an energy source to energize the restriction device and controlling the energy source to release energy for use in connection with the operation of the restriction device. The method may further comprise using the energy released from the energy source to operate the restriction device to open and close, respectively, the urinary passage.

According to a second alternative method, a method is provided for treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparoscopic trocars in the patient's body, inserting a dissection tool through the trocars, and dissect an area of ​​the urethra or urinary bladder, place an operable restriction device in the dissected area, so that the restriction device engages the urethra or urinary bladder to form a restricted urinary passage in the urethra or urinary bladder, implant a source of energy in the patient, and control the implanted source of energy from outside the patient's body to release energy for use in connection with the operation of the restriction device.

According to a third alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising: (a) surgically implanting into the patient an operable restriction device that engages the patient's urethra or urinary bladder to form a restricted urinary passage in the urethra or urinary bladder. (b) Provide an external energy source to the patient's body. (c) Controlling the external power source from outside the patient's body to release wireless power. And (d) using the released wireless energy in conjunction with the operation of the restriction device.

The method may further comprise (e) implanting the human or animal with an operating device that can adjust the restricted urinary passage in response to delivered energy, and (f) using the released wireless energy to activate the implanted operating device to ( i) enlarge the restricted urinary passage to allow urine to pass easily through it but normally restrict the urinary passage. In procedure (f) it can be practiced at least once a day, usually several times (eg 2-10) in a day.

According to a fourth alternative method, a method is provided for treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparoscopic trocars in the patient's body, inserting a dissection tool through the trocars, and dissect an area of ​​the urethra or urinary bladder, place an operable restriction device in the dissected area, so that the restriction device engages the urethra or bladder to form a restricted urinary passage in the urethra or urinary bladder, provide an external source of energy outside the patient's body, control the external source of energy from outside the patient's body to release wireless energy, and to use the released wireless energy in conjunction with the operation of the restriction device.

According to a fifth alternative method, a method is provided for treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparoscopic trocars in the patient's body, inserting a dissection tool through the trocars, and dissect an area of ​​the urethra or urinary bladder, implant an operable restriction device in the dissected area, so that the restriction device engages the urethra or urinary bladder to form a restricted urinary passage in the urethra or urinary bladder, implant an energy transformation device, provide an external source of energy, control the external source of energy to release energy wireless and transform wireless power by transforming device

ES 2 249 407 T3 energy in energy other than wireless energy for use in connection with the operation of the restriction device. This procedure may further comprise implanting a stabilizer in the patient to stabilize the energy transformed by the energy transformation device.

The invention is described in more detail in the following with reference to the accompanying drawings, in which

Figures 1 through 6 are schematic block diagrams illustrating six embodiments, respectively, of the invention, in which wireless energy released from an external power source is used for direct operation of a restriction device that engages the urethra or urinary bladder of a patient;

Figures 7 to 10 are schematic block diagrams illustrating four embodiments, respectively, of the invention, in which energy is released from an implanted source of energy;

Figures 11 to 15 are schematic block diagrams illustrating five embodiments, respectively, of the invention, in which a switch is implanted in the patient to directly or indirectly switch operation of the restriction device;

Figure 16 is a schematic block diagram illustrating conceivable combinations of implantable components to achieve various communication options;

Figure 17 illustrates the apparatus according to the invention implanted in a patient;

Figure 18 is a block diagram illustrating the remote control components of one embodiment of the invention; Y

Figure 19 is a schematic view of the example circuitry used for the components of the block diagram of Figure 18.

With reference to the Figures of the drawings, like reference numerals designate identical or corresponding elements throughout the various Figures.

Figure 1 schematically shows an embodiment of the urinary incontinence treatment apparatus of the invention, which has some parts implanted in a patient and other parts located outside the patient's body. In this way, in Figure 1 all the parts placed to the right of the patient's skin 2 are implanted and all the parts placed to the left of the skin 2 are located outside the patient's body. The apparatus of Figure 1 comprises an implanted, operable restriction device 4 that engages the urethra (or alternatively the urinary bladder) of the patient to form a restricted urinary passage. The restriction device 4 is capable of performing a reversible function, that is, opening and closing the urinary passage. An implanted control unit 6 controls the restriction device 4 via the control line 8 to form a suitable restriction of the urinary passage. An external control unit 10 includes an external power source and a wireless remote control that transmits a control signal generated by the external power source. The control signal is received by a signal receiver incorporated in the implanted control unit 6, whereby the control unit 6 controls the implanted restriction device 4 in response to the control signal. The implanted control unit 6 also uses energy from the control signal to operate the restriction device 4 via a power supply line 12.

Figure 2 shows an embodiment of the invention identical to that of Figure 1, except that a reversal device in the form of a power-operable switch 14 is also implanted in the patient to reverse the restriction device 4. The control unit 6 uses the switch 14 to reverse the function performed by the restriction device 4. More precisely, the external control unit 10 releases energy carried by a wireless signal and the implanted control unit 6 transforms the wireless energy into a current to operate the switch 14. When the control unit 6 changes the polarity of the current , the switch 14 reverses the function performed by the restriction device 4.

Figure 3 shows an embodiment of the invention identical to that of Figure 1, except that an operating device in the form of a motor 16 is also implanted in the patient. The implanted control unit 6 supplies the motor 16 with the wireless energy released by the external power source of the external control unit 10. The implanted control unit 6 controls the operation of the motor 16 in response to a control signal from the remote control of the external control unit 10.

Figure 4 shows an embodiment of the invention identical to that of Figure 1, except that an assembly 16 including a motor / pump unit 18 and a fluid reservoir 20 is also implanted in the patient. In this case, the restriction device 4 is hydraulically operated, that is, hydraulic fluid is pumped by the motor / pump unit 18 from the reservoir 20 through a conduit 22 to the restriction device 4 to restrict the urinary passage and is pumps hydraulic fluid through motor / pump unit 18 back from restriction device 4 to reservoir 20 to enlarge the urinary passage. The external control unit 10 releases energy carried by a wireless signal and the implanted control unit 6 transforms the wireless energy into a current, for example a current, to power the motor / pump unit 18 via a power supply line 24. electric power. Unit

The implanted control ES 2 249 407 T3 controls motor / pump unit 16 and restriction device 4 via control lines 26 and 27.

Figure 5 shows an embodiment of the invention comprising the hydraulically operated restriction device 4 and the implanted control unit 6 and further comprising a hydraulic fluid reservoir 230, a motor / pump unit 232 and a reversal device. in the form of a hydraulic valve displacement device 234, all of which are implanted in the patient. The motor of the motor / pump unit 232 is an electric motor.

Figure 6 shows an embodiment of the invention identical to that of Figure 1, except that an accumulator 28 is also implanted in the patient. The control unit 6 stores energy received from the external control unit 10 in the accumulator 28. In response to a control signal from the external control unit 10, the implanted control unit 6 releases energy from the accumulator 28 via a power line. energy 30 for the operation of the restriction device 4.

Figure 7 shows an embodiment of the invention comprising the hydraulically operated restriction device 4 and the implanted control unit 6 and further comprising a power source in the form of a battery 32, a hydraulic fluid reservoir 34, a motor / pump unit 36 ​​and a reversal device in the form of a hydraulic valve displacement device 38 all of which are implanted in the patient. The motor of the motor / pump unit 36 ​​is an electric motor. An external control unit 40 includes a wireless remote control that transmits a control signal that is received by the signal receiver incorporated in the implanted control unit 6.

In response to a control signal from the external control unit 40, the implanted control unit 6 supplies the motor / pump unit 36 ​​with power from the battery 32, whereby the motor / pump unit 36 ​​distributes hydraulic fluid between reservoir 34 and restriction device 4. The control unit 6 controls the shift or shift device 38 to change the flow direction of the hydraulic fluid between a direction in which the fluid is pumped by the motor / pump unit 36 ​​from the reservoir 34 to the restriction device 4 to restricting the urinary passage, and another opposite direction in which fluid is pumped by the motor / pump unit 36 ​​back from the restriction device 4 to the reservoir 34 to enlarge the urinary passage.

Figure 8 shows an embodiment of the invention identical to that of Figure 6, except that a battery 42 is replaced by the accumulator 28, the control unit 40 of the embodiment of Figure 5 is replaced by the external control unit 10 and An electric motor 44 is implanted in the patient to operate the restriction device 4. In response to a control signal from the external control unit 40, the implanted control unit 6 supplies the motor 44 with power from the battery 42, whereby the motor 44 operates from the restriction device 4.

Figure 9 shows an embodiment of the invention identical to that of Figure 8, except that the motor / pump unit 36 ​​of the embodiment of Figure 7 is replaced by the motor 44 and a reservoir 46 is also implanted in the patient. fluid. Reservoir 46 is via fluid lines 48 and 50 connected to motor / pump unit 36 ​​and restriction device 4, which in this case is hydraulically operated. In response to a control signal from the external control unit 40, the implanted control unit 6 supplies the electric motor of the motor / pump unit 36 ​​with power from the battery 42, whereby the motor / pump unit 36 distributes hydraulic fluid between fluid reservoir 46 and restriction device 4.

Figure 10 shows an embodiment of the invention identical to that of Figure 8, except that a mechanical reversal device in the form of a gearbox 52 is also implanted in the patient. The implanted control unit 6 controls the gearbox 52 to reverse the function performed with the restriction device 4 (mechanically operated).

Figure 11 shows an embodiment of the invention comprising the restriction device 4, the external control unit 10, an implanted power source 236, and an implanted switch 238. The switch 238 is operated by wireless energy released from the external power source of the external control unit 6 to switch between an off mode, in which the implanted power source 236 is not in use, and an on mode, in which the implanted power source 236 supplies power for the operation of the restriction device 4.

Figure 12 shows an embodiment of the invention identical to that of Figure 11, except that also the control unit 6 is implanted, in order to receive a control signal from the wireless remote control of the external control unit 10. The switch 238 is operated by the wireless power of the external power source 10 to switch between an off mode, in which the implanted power source 236 and the wireless remote control of the external control unit 10 are not in use. that is, the control unit 6 is not capable of receiving the control signal and a standby mode, in which the wireless remote control is allowed to control the internal power source 236, by the implanted control unit 6, to supply power for the operation of the restriction device 4.

Figure 13 shows an embodiment of the invention identical to that of Figure 12, except that an energy transformation device for transforming wireless energy into storable energy is incorporated into the implanted control unit 6 and that the implanted energy source 236 it is of a type that is capable of storing storable energy. In this case, in response to a control signal from the external control unit 10, the control unit 6

ES 2 249 407 T3 implanted control controls switch 238 to switch from an off mode, in which the implanted power source 236 is not in use, to an on mode, in which power source 36 supplies power for operation of the restriction device 4.

Figure 14 shows an embodiment of the invention identical to that of Figure 13, except that an energy storage device 240 is also implanted in the patient to store the storable energy transformed by wireless energy by the transformation device of the unit. 6 control. In this case, the implanted control unit 6 controls the energy storage device 240 to operate the switch 238 to switch between an off mode, in which the implanted source of energy 236 is not in use, and an on mode, in the which the implanted power source 236 supplies power for the operation of the restriction device 4.

Figure 15 shows an embodiment of the invention identical to that of Figure 13, except that a motor 242 and a mechanical reversal device in the form of a gearbox 244 are also implanted in the patient. The implanted control unit 6 controls the gearbox 244 to reverse the function performed by the restriction device 4 (mechanically operated), that is, to enlarge and restrict the urinary passage.

Figure 16 schematically shows conceivable combinations of implanted components of the apparatus to achieve various communication possibilities. Basically, there are the implanted restriction device 4, the implanted control unit 6 and the external control unit 10 including the external power source and the wireless remote control. As already described above, the remote control transmits a control signal generated by the external power source and the control signal is received by a signal receiver incorporated in the implanted control unit 6 whereby the control unit 6 controls the restriction device 4 implanted in response to the control signal.

A sensor 54 may be implanted in the patient to sense a physical parameter of the patient, such as pressure in the stomach. The control unit 6, or alternatively the external control unit 10, can control the restriction device 4 in response to signals from the sensor 54. A transceiver can be combined with the sensor 54 to send information of the perceived physical parameter to the unit. 10 external control. The wireless remote control of the external control unit 10 may comprise a signal transmitter or transceiver and the implanted control unit 6 may comprise a signal receiver or transceiver. Alternatively, the wireless remote control of the external control unit 10 may comprise a signal receiver or transceiver and the implanted control unit 6 may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers can be used to send information or data related to the restriction device from inside the patient's body to the outside of the patient.

The motor 44 can be implanted to operate the restriction device 4 and also the battery 32 can be implanted to drive the motor 44. The battery 32 can be equipped with a transceiver to send information of the battery charge condition.

Those skilled in the art will appreciate that the various above embodiments according to Figures 115 can be combined in many different ways. For example, the power operated switch 14 can be incorporated into any of the embodiments of Figures 4, 6, 8-10. Hydraulic shift or shift device 38 may be incorporated into any of the embodiments of Figures 4 and 9. Gearbox 52 can be incorporated into any of the embodiments of Figures 1, 6, and 8.

Figure 17 illustrates how any of the above-described embodiments of the apparatus of the invention can be implemented in a patient. Thus, an apparatus assembly implanted in the patient comprises a restriction device 56 that couples the urethra 58, an operating device 60 for operating the restriction device 56, and an internal control unit 62, including a signal receiver. , to control the operating device 61. An external control unit 64 includes a signal transmitter for transmitting a wireless control signal to the signal receiver of the implanted control unit 62. The implanted control unit 62 is capable of transforming the signal energy of the control signal into electrical energy to power the operating device 60 and to power the energy consuming components of the implanted apparatus.

Figure 18 shows the basic parts of a wireless remote control of the apparatus of the invention that includes an electric motor 128 for operating a restriction device, for example of the type illustrated in Figure 17. In this case, the remote control is based on the transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz - 1 gHz, through the skin 130 of the patient. In Figure 18, all of the parts positioned to the left of the skin 130 are located outside the patient's body and all the parts positioned to the right of the skin 130 are implanted. Any suitable remote control system can be used.

An external, signal transmitting antenna 132 to be positioned close to a signal receiving antenna 134 implanted close to the skin 130. As an alternative, the receiving antenna 134 may be positioned, for example, within the abdomen of the patient. The receive antenna 134 comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter, wound with a very thin wire and tuned to a capacitor at a specific high frequency. A small coil is chosen if it is to be implanted under the patient's skin and a large coil is chosen if it is to be implanted in the patient's abdomen. The transmitting antenna 132 comprises a coil that has approximately the same restriction as the coil of the receiving antenna 134 but wound with a

ES 2 249 407 T3 thick wire that can handle the large currents that are needed. The coil of the transmitting antenna 132 is tuned to the same specific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a high frequency electromagnetic wave signal generator, and a power amplifier. The microprocessor in the control unit 136 is adapted to turn the generator on / off and to modulate the signals generated by the generator to send digital information via the power amplifier and antennas 132, 134 to an implanted control unit 138. To prevent accidental random high-frequency fields from triggering control commands, digital signal codes are used. A conventional keyboard placed in the external control unit 136 is connected to the microprocessor thereof. The keyboard is used to command the microprocessor to send digital signals to activate the restriction device to either restrict or enlarge the urinary passage. The microprocessor initiates a command by applying a high frequency signal to antenna 132. After a short time when the signal has energized the implanted parts of the control system, commands are sent to restrict or enlarge the urinary passage in predefined steps. Orders are shipped as digital packages as illustrated below.

<td>Start Pattern, 8 bit</td><td>Order, 8 bits</td><td>Count, 8 bits</td><td>Checksum, 8 bits</td>

Orders are sent continuously for a rather long period of time (for example, approximately 30 seconds or more). When a new restriction or enlargement step is desired, the count byte is incremented by one to allow the implemented control unit 138 to decode and understand that another step is commanded by the external control unit 136. If any part of the digital package is wrong, its content is simply ignored.

Through a line 140, an implanted energizer unit 126 extracts energy from the high frequency electromagnetic wave signals received by the receiving antenna 134. Energizer unit 126 stores energy in a power supply, such as a large capacitor, powers control unit 138, and drives electric motor 128 via line 142.

Control unit 138 comprises a demodulator and a microprocessor. The demodulator demodulates the digital signals sent from the external control unit 136. The microprocessor of the control unit 138 receives the digital packet, decodes it, and on the condition that the power supply of the energizer unit 126 has sufficient stored energy, sends a signal via a signal line 144 to the motor 128 to either shrink or enlarge the restriction device depending on the order code received.

Alternatively, the energy stored in the energizer unit power supply can only be used to drive a switch, and the power to drive the motor 128 can be obtained from another relatively high capacity implanted power source, for example , A battery. In this case, the switch is adapted to connect the battery to the control unit 138 in an on mode when the switch is powered by the power supply and to keep the battery disconnected from the control unit in a standby mode when turns off the switch.

With reference to Figure 19, the remote control schematically described above will now be described in accordance with a more detailed embodiment. The external control unit 136 comprises a microprocessor 146, a signal generator 148, and a power amplifier 150 connected thereto. The M icroprocesador 146 is adapted to turn on / off the signal generator 148 and to modulate signals generated by the generator 148 with digital commands signal sent to implanted components of the apparatus. The power amplifier 150 amplifies the signals and sends them to the external signal transmitting antenna 132. Antenna 132 is connected in parallel with a capacitor 152 to form a resonant circuit tuned to the frequency generated by signal generator 148.

The implanted signal receiving antenna coil 134 together with a capacitor 154 forms a resonant circuit that is tuned to the same frequency as the transmitting antenna 132. The signal receiving antenna coil 134 includes a current of the waves high-frequency electromagnetic signals received and a rectifying diode 160 rectifies the induced current, which charges a storage capacitor 158. A coil 156 connected between antenna coil 134 and diode 160 prevents capacitor 158 and diode 160 from loading the circuit of high frequency signal receiving antenna 134. In this way, coil 156 makes it possible to charge capacitor 158 and transmit the digital information using amplitude modulation.

A capacitor 162 and a resistor 164 connected in parallel and a diode 166 form a detector used to detect amplitude modulated digital information. A filter circuit is formed by a resistor 168 connected in series with a resistor 170 connected in series with a capacitor 172 connected in series with resistor 168 by ground and a capacitor 174, a terminal of which is connected between resistor 168, 170 and the other terminal of which is connected between diode 166 and the circuit formed by capacitor 162 and resistor 164. The filter circuit is used to filter out undesirable high and low frequencies. The sensed and filtered signals are fed to an implanted microprocessor 176 that decodes the digital information and controls a motor 128 via H-bridge 178 comprising transistors 180, 182, 184 and 186. Motor 128 can drive or drive in two opposite directions over the H 178 bridge.

ES 2 249 407 T3

Microprocessor 176 also monitors the amount of energy stored in storage capacitor 158. Before sending signals to drive motor 128, microprocessor 176 checks if the energy stored in storage capacitor 158 is sufficient. If the stored energy is not sufficient to perform the requested operation, the microprocessor 176 waits for the received signals to charge the storage capacitor 158 before turning on the motor 128.